A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
This research project will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of MS fatigue.
详细描述
Fatigue is a major cause of disability in MS and is associated with a reduced quality of life. Treatment options for MS fatigue include central nervous system stimulants and amantadine. These medications are of limited efficacy, are often poorly tolerated, and can be expensive. Ginseng may represent a novel approach to treating MS fatigue. Ginseng has been tested in clinical trials for its ability to improve mental alertness and fatigue. However, there have been no published clinical trials addressing the effects of ginseng in subjects with MS, even though many people with MS use ginseng and report deriving benefit from it.
This double-blinded, placebo controlled crossover pilot study will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs. placebo for the treatment of MS fatigue. Additionally, the project will collect information on the impact of ginseng on cognition, stress, actigraphy, salivary cortisol, differential cytokine response, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS as diagnosed by the McDonald criteria
- •Complaint of fatigue that has been persistent for at least 2 months
- •FSS score of 4 or greater;
- •Age 18-70.
排除标准
- •Use of ginseng or stimulants in the prior 6 weeks
- •Acute treatment with glucocorticoids in the prior 6 weeks
- •Significant MS exacerbation in prior 30 days
- •Uncontrolled hypertension
- •Other serious medical disease, pregnancy or breastfeeding
- •Breast disease
- •Abnormal bleeding or clotting disorder
- •Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline, isocarboxazid, or phenelzine
- •Current use of lasix for poorly controlled hypertension or congestive heart failure
- •Current drug or alcohol abuse; inability to complete the self report forms
研究组 & 干预措施
1
Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo
干预措施: American ginseng extract HT-1001 (Drug)
1
Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo
干预措施: placebo (Drug)
2
Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention
干预措施: American ginseng extract HT-1001 (Drug)
2
Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention
干预措施: placebo (Drug)
结局指标
主要结局
Fatigue Severity Scale
时间窗: after 6 weeks of intervention
The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.
次要结局
- Modified Fatigue Impact Scale(6 weeks of intervention)
- Realtime Digital Fatigue Score(6 weeks of intervention)
研究者
Ruth Whitham
Professor of Neurology
Oregon Health and Science University